Japan Statin Treatment Against Recurrent Stroke (J-STARS)

Ischemic Stroke Clinical Trial

Official title:

Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221104
• Other study ID #: J-STARS
• Secondary ID: C000000207
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: June 19, 2017
• Start date: March 1, 2004

Study information

• Verified date: June 2017
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1578
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset

• Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days

• Able to visit outpatient department

• Informed consent on the form.

Exclusion Criteria:

• Ischemic stroke of other determined cause according to the TOAST classification

• Ischemic heart disease and necessary to use statin

• Hemorrhagic disorders

• Platelet count <=100,000/ul within 3 months prior to study start

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>= 100IU/L within 3 months prior to study start

• Serum creatinine >=2.0mg/dl within 3 months prior to study start

• A scheduled operation

• The presence of malignant disorder

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• Pravastatin

Locations

Country	Name	City	State
Japan	Hiroshima University	Hiroshima

Sponsors (3)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Hiroshima University, Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rate of Stroke and TIA	Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)	up to 5 years
Secondary	Incidence Rate of Atherothrombotic Infarction	Incidence rate of patients with atherothrombotic infarction	up to 5 years
Secondary	Incidence Rate of Lacunar Infarction	Incidence rate of patients with lacunar infarction	up to 5 years
Secondary	Incidence Rate of Cardioembolic Infarction	Incidence rate of patients with cardioembolic infarction	up to 5 years
Secondary	Incidence Rate of Intracranial Hemorrhage	Incidence rate of patients with intracranial hemorrhage	up to 5 years

External Links

•   Japan Statin Treatment Against Recurrent Stroke (J-STARS) only in Japanese